Japan

Serving the Needs of Domestic and Global Clients in Japan

We support a wide array of companies, both domestic and local, to efficiently and successfully bring their new products to markets worldwide.

Ora’s pre-clinical and clinical models, unique clinical methodologies and regulatory experience as well as expertise, have been refined and proven across thousands of projects both in the US and internationally. We bring together the world’s most extensive and experienced network of ophthalmic experts and R&D professionals to maximize the value of new product initiatives.

Ora Japan is the local regulatory and clinical operations center for Ora, the world’s leading ophthalmic development services provider. Ora Japan is located in downtown Osaka and Tokyo, within the heart of Japan’s biotech corridor.

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  • Strategic Consulting & Indication Selection
  • Study and Clinical Program Design
  • KOL Advisory Board Meeting
  • CMC Management
  • Pharmacology/Toxicology
  • Preclinical Models
  • Turnkey Clinical CRO Services: Phase I – IV
  • Data Management
  • Biostatistics
  • IDE/510K/PMA/PIND/Scientific Advice/End of Phase 2/Pre-NDA Meetings
  • Regulatory Submissions/Briefing Packages and regulatory authority interface (FDA, EMA and PMDA)
  • Medical Writing and Publication Support
  • Support for Marketing, Advertising, and Product Commercialization
  • Product/Pipeline Analysis to Evaluate Assets for Ophthalmic Indications
  • Supporting Entrepreneurs, Biotech, Start-ups, and Pharma
  • Strategic Business and Development Planning
  • Due Diligence Support (Business and Technical)
  • Network of Investors and Pharmaceutical Partners
  • Access to Deal Flow
  • Strategic Partner for Ophthalmology Companies and Companies New to Ophthalmology
  • Japan Companies considering development pathways in the US/EU
  • Companies external to Japan looking to develop in Japan
  • Japanese Companies with products seeking partners outside Japan
  • Companies looking for pharma partners in Japan

Clinical Models, Endpoints, and Scales

Ora is the leading pharmaceutical and device services expert in all indications of the eye, including the front and back of the eye. We have developed validated clinical models that are accepted as regulatory endpoints in allergic conjunctivitis (Ora-CAC® model), dry eye (CAE®) and inherited retinal diseases (Ora-VNC™ mobility course). We will collaborate with you to design the optimal study and the associated endpoints to accelerate your timelines and achieve the goal of your program.

Ora has partnered with many companies to develop novel anti-allergic products efficiently and reliably in Japan. It uses its Ora-CAC® model, as well as other models to our partner’s benefit. Ora uses its standard CAC® (e.g. anti-histamine) and modified CAC® (e.g. anti-inflammatory) to accelerate the development of innovative therapies with a broad range of mechanism of actions. Ora has partnered with the Kitasato Institute to bring the standard Ora-CAC® allergy models to Japan and integrating with the experimental operations at Kitasato Institute.

Learn more about Ora Japan

To learn more about Ora Japan’s capabilities, fill out the form below to download our brochure.

Ora Japan K.K.
18F, Hilton Plaza West Office Tower
2-2-2 Umeda, Kita-ku
Osaka 530-0001, Japan
tel: +(81)-6-6133-4393
fax: +(81)-6-6133-4394

Ora Japan K.K. (Tokyo Office)
3F, Asahi Seimei Otemachi Building
2-6-1 Otemachi, Chiyoda-ku
Tokyo 100-0004, Japan